Sanofi launches Rezurock against chronic Graft-versus-host disease in India

Drugmaker Sanofi Healthcare India on Monday said it has received marketing authorization for Rezurock (belumosudil tablets) in India for treatment of chronic Graft-versus-host disease (GVHD) in patients 12 years and above.

Rezurock is used in treatment cGVHD patients globally (12 years and above), after failure of two previous lines of treatment, including those with difficult-to-treat manifestations like fibrosis.

Rezurock occurs when a donor's cells attack the recipient's healthy cells, it occurs in bone marrow transplants.


Rezurock was approved by the USFDA in 2021 and by the CDSCO in India in 2024 based on safety and efficacy results from ROCKstar – a randomized, open-label, multicenter pivotal trial of Rezurock in patients with cGVHD who had received two to five prior lines of systemic therapy.

Administered once daily (orally), Rezurock 200 mg achieved an overall response rate (ORR) of 74% and has shown robust and durable responses across the spectrum of cGVHD, Sanofi said in a press release.

"It is safe and well-tolerated with adverse events being consistent to those expected in patients with advanced cGVHD receiving corticosteroids and/or other immunosuppressants," the release added.

“cGVHD has a debilitating impact on the day-to-day functioning of those suffering from it, treatment options for people suffering from it are very limited," said Rodolfo Hrosz, MD of Sanofi India.

"The introduction of Rezurock reinforces Sanofi India’s leadership in the field of immunology and transplant care,” Hrosz added.